Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
Conditions
Non-Hodgkin's Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Rituximab Type: Drug
Name: DHAP Type: Drug
Name: TEC Type: Drug
Name: autologous stem cell transplantation Type: Drug
Overall Status
Recruiting
Summary
This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Hodgkins's Lymphoma.
Detailed Description
Initial Cytoreduction is performed with DHAP- protocol using dexamethasone, cytarabine and cisplatin followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (TEC) an autologous peripheral blood stem cell transplantation(aPBSCT). In case of only partial remission a second identical high dose chemotherapy and aPBSCT follows. Patients with primary refractory disease or early relapse within 6 months should receive a allogenous stem cell transplantation. For Patients with CD 20 positive B-cell lymphoma the chemotherapy regiments DHAP and TEC are combined with rituximab.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- first relapse or primary refractory disease of aggressive Non-Hodgkin's lymphoma stage I-IV

- pretreatment with systemic therapy

- 18-65 years of age

- Performance status:ECOG 0-2

- Granulocyte count >1.5/µm3, Platelet count >100/µm3

- Creatinine -Clearance ≥ 1 ml/sec

- GPT/GOT ≤ 1.5 x normal (except tumour related)

- Bilirubine < 22 µmol/l

- no participation in another study 3 month before and during this study −informed consent

Exclusion Criteria:

- Second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia

- CNS- involvement by lymphoma

- respiratory Partial- or global insufficiency

- cardiac insufficiency (NYHA-Stage 3-4, EF < 30 %)

- severe neurological or psychiatric disease

- pregnancy

- HIV positivity ,active virus hepatitis, bacterial infection − No follow up procedures ensured
Location
University of Magdeburg
Magdeburg, Germany
Status: Recruiting
Start Date
June 2004
Completion Date
June 2010
Sponsors
University of Magdeburg
Source
University of Magdeburg
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page